A retrospective observational study in 3 Nordic countries suggests an increased risk of neurodevelopmental disorders (NDDs) in children (from 0 to 11 years old) born to men treated with valproate as monotherapy in the 3 months prior to conception compared to those born to men treated with lamotrigine or levetiracetam as monotherapy.

Due to study limitation, this risk is possible but is not confirmed.

It is recommended that in male patients valproate is initiated and supervised by a specialist experienced in treatment of epilepsy, bipolar disorder <or migraine>.

Prescribers should inform male patients about the potential risk and discuss with them the need to consider effective contraception, including for a female partner, while using valproate and for 3 months after stopping the treatment.